# K973775: Harpoon Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 16, 1998 after 195 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
68 later devices descend from it; 8 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K012572: Soft Tissue Screw and Washer (2001), 47 descendants of its own
- K012872: Resorbable Screw Anchor (2001), 30 descendants of its own
- K041274: Resorbable Interference Screw (2004), 26 descendants of its own
- K012503: Metal Screw Anchor (2001), 17 descendants of its own
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (2004), 15 descendants of its own

## Indications for use
1) Shoulder (Harpoon and Mini-Harpoon Suture Anchors) Bankart repair, SLAP lesion repair, -acromio-clavicular separation repair, rototar cuff repair, capsule repair and capsulolabral reconstruction, Biceps tendosis, deltoid reg 2) Wrist (Mini-Harpoon Suture Anchor only) Scapholunate ligament reconstruction 3) Elbow (Harpoon and Mini-Harpoon Suture Anchoré) Biceps tendon reattachment, Ulnar or radial collateral -‘ligament reconstruction . 4) Knee (Harpoon and Mini-Harpoon Suture -Anchors) Extra-Capsular Repair:’ : ' Medial collateral ligament. repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and repair, patellar ligament and tendon repair, vastus medialis obliguus VMO) muscle advancement

Source page: https://510kreport.com/device/K973775
Methodology: https://510kreport.com/methodology